PADI试验的长期随访：经皮腔内血管成形术与药物洗脱支架治疗严重肢体缺血的腘下病变对比研究
Long-Term Follow-up of the PADI Trial: Percutaneous Transluminal Angioplasty Versus Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia.
作者信息
Spreen Marlon I, Martens Jasper M, Knippenberg Bob, van Dijk Lukas C, de Vries Jean-Paul P M, Vos Jan Albert, de Borst Gert Jan, Vonken Evert-Jan P A, Bijlstra Okker D, Wever Jan J, Statius van Eps Randolph G, Mali Willem P Th M, van Overhagen Hendrik
机构信息
Department of Radiology, Haga Teaching Hospital, The Hague, The Netherlands.
Department of Vascular Surgery, Haga Teaching Hospital, The Hague, The Netherlands.
出版信息
J Am Heart Assoc. 2017 Apr 14;6(4):e004877. doi: 10.1161/JAHA.116.004877.
BACKGROUND
Clinical outcomes reported after treatment of infrapopliteal lesions with drug-eluting stents (DESs) have been more favorable compared with percutaneous transluminal angioplasty with a bailout bare metal stent (PTA-BMS) through midterm follow-up in patients with critical limb ischemia. In the present study, long-term results of treatment of infrapopliteal lesions with DESs are presented.
METHODS AND RESULTS
Adults with critical limb ischemia (Rutherford category ≥4) and infrapopliteal lesions were randomized to receive PTA-BMS or DESs with paclitaxel. Long-term follow-up consisted of annual assessments up to 5 years after treatment or until a clinical end point was reached. Clinical end points were major amputation (above ankle level), infrapopliteal surgical or endovascular reintervention, and death. Preserved primary patency (≤50% restenosis) of treated lesions was an additional morphological end point, assessed by duplex sonography. In total, 74 limbs (73 patients) were treated with DESs and 66 limbs (64 patients) were treated with PTA-BMS. The estimated 5-year major amputation rate was lower in the DES arm (19.3% versus 34.0% for PTA-BMS; =0.091). The 5-year rates of amputation- and event-free survival (survival free from major amputation or reintervention) were significantly higher in the DES arm compared with PTA-BMS (31.8% versus 20.4%, =0.043; and 26.2% versus 15.3%, =0.041, respectively). Survival rates were comparable. The limited available morphological results showed higher preserved patency rates after DESs than after PTA-BMS at 1, 3, and 4 years of follow-up.
CONCLUSIONS
Both clinical and morphological long-term results after treatment of infrapopliteal lesions in patients with critical limb ischemia are improved with DES compared with PTA-BMS.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00471289.
背景
对于严重肢体缺血患者，中期随访结果显示，与单纯球囊血管成形术联合补救性裸金属支架置入术（PTA-BMS）相比，药物洗脱支架（DES）治疗腘动脉以下病变后的临床结局更优。在本研究中，我们展示了DES治疗腘动脉以下病变的长期结果。
方法与结果
患有严重肢体缺血（卢瑟福分级≥4级）且伴有腘动脉以下病变的成人患者被随机分为两组，分别接受PTA-BMS或含紫杉醇的DES治疗。长期随访包括治疗后长达5年的年度评估，或直至达到临床终点。临床终点包括大截肢（踝关节以上水平）、腘动脉以下手术或血管腔内再次干预以及死亡。通过双功超声评估治疗病变的保留原发性通畅率（再狭窄≤50%）作为额外的形态学终点。总共74条肢体（73例患者）接受了DES治疗，66条肢体（64例患者）接受了PTA-BMS治疗。DES组的估计5年大截肢率较低（19.3%，而PTA-BMS组为34.0%；P=0.091）。与PTA-BMS组相比，DES组的5年截肢和无事件生存率（无大截肢或再次干预的生存率）显著更高（分别为31.8%对20.4%，P=0.043；以及26.2%对15.3%，P=0.041）。生存率相当。有限的可用形态学结果显示，在随访1年、3年和4年时，DES治疗后的通畅保留率高于PTA-BMS。
结论
与PTA-BMS相比，DES治疗严重肢体缺血患者腘动脉以下病变后的临床和形态学长期结果均得到改善。
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